
The Kalea Trial is evaluating the effectiveness and safety of an investigational product for adults with MDD who are currently in a depressive episode with moderate to severe symptoms lasting at least 1 month to no more than 2 years, have previously had at least 1 depressive episode, and have tried at least 1 oral (by mouth) antidepressant for a prior or current major depressive episode.
During the double-blind treatment period, participants will be randomly assigned to 1 of 2 groups to receive either the investigational treatment or a placebo (a substance that looks like the investigational treatment but contains no active ingredients), both given as injections. “Double-blind” means that neither you nor the trial doctor or staff will know which treatment you are receiving. Eligible participants may also take part in an open-label treatment period, during which all participants will receive the investigational treatment.
Throughout the trial, participants will have scheduled visits at the trial clinic for health exams and tests. They will also have up to 2 telehealth visits with the trial doctor/staff. Between trial visits, they will not have to record data nor take investigational product at home.
Total participation will include up to 10 trial visits over the course of approximately 28 weeks. Some visits will take place virtually.
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